Xia 3 System - SerratoRecalls & reported problems across all models
Stryker Corporation · 36 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 103
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls
- 1
We found 36 models of Xia 3 System - Serrato by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 103 adverse event reports in the FDA's MAUDE database, received between Nov 1, 2017 and Jun 8, 2026 — classified as 50 injuries, 53 malfunctions.
The most frequently reported specific device problem is “Fracture” (35 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Xia 3 System - Serrato recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 18, 2019Terminated
Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.
Z-2160-2019 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported Xia 3 System - Serrato problems
Device problems
- Fracture35
- Migration20
- Material Separation18
- Detachment of Device or Device Component17
- Break16
- Appropriate Device Problem Term/Code Not Available8
- Loose or Intermittent Connection7
- Device Dislodged or Dislocated5
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- Injury24
- Pain23
- No Known Impact Or Consequence To Patient19
- No Consequences Or Impact To Patient9
- Bone Fracture(s)5
- Device Embedded In Tissue or Plaque3
- Insufficient Information3
Xia 3 System - Serrato models
36 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Xia 3 System - Serrato 482619590Thoracolumbosacral pedicle screw system1 recall6 reports
- Xia 3 System - Serrato 482616545Thoracolumbosacral pedicle screw system17 reports
- Xia 3 System - Serrato 482616550Thoracolumbosacral pedicle screw system9 reports
- Xia 3 System - Serrato 482616540Thoracolumbosacral pedicle screw system6 reports
- Xia 3 System - Serrato 482677580Thoracolumbosacral pedicle screw system5 reports
- Xia 3 System - Serrato 482617545Thoracolumbosacral pedicle screw system4 reports
- Xia 3 System - Serrato 482617050Thoracolumbosacral pedicle screw system4 reports
- Xia 3 System - Serrato 482618570Thoracolumbosacral pedicle screw system4 reports
- Xia 3 System - Serrato 482678580Thoracolumbosacral pedicle screw system4 reports
- Xia 3 System - Serrato 48268011ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- Xia 3 System - Serrato 4826195100Thoracolumbosacral pedicle screw system3 reports
- Xia 3 System - Serrato 482619580Thoracolumbosacral pedicle screw system3 reports
- Xia 3 System - Serrato 482618550Thoracolumbosacral pedicle screw system3 reports
- Xia 3 System - Serrato 482617550Thoracolumbosacral pedicle screw system3 reports
- Xia 3 System - Serrato 482618580Thoracolumbosacral pedicle screw system2 reports
- Xia 3 System - Serrato 482619540Thoracolumbosacral pedicle screw system2 reports
- Xia 3 System - Serrato 482618545Thoracolumbosacral pedicle screw system2 reports
- Xia 3 System - Serrato 482626545Thoracolumbosacral pedicle screw system2 reports
- Xia 3 System - Serrato 482619560Thoracolumbosacral pedicle screw system2 reports
- Xia 3 System - Serrato 482617045Thoracolumbosacral pedicle screw system2 reports
- Xia 3 System - Serrato 482627540Thoracolumbosacral pedicle screw system1 report
- Xia 3 System - Serrato 482619555Thoracolumbosacral pedicle screw system1 report
- Xia 3 System - Serrato 482678570Thoracolumbosacral pedicle screw system1 report
- Xia 3 System - Serrato 482616040Thoracolumbosacral pedicle screw system1 report
- Xia 3 System - Serrato 482619550Thoracolumbosacral pedicle screw system1 report
- Xia 3 System - Serrato 482615540Thoracolumbosacral pedicle screw system1 report
- Xia 3 System - Serrato 482626540Thoracolumbosacral pedicle screw system1 report
- Xia 3 System - Serrato 482677570Thoracolumbosacral pedicle screw system1 report
- Xia 3 System - Serrato 482615545Thoracolumbosacral pedicle screw system1 report
- Xia 3 System - Serrato 482616555Thoracolumbosacral pedicle screw system1 report
- Xia 3 System - Serrato 482616050Thoracolumbosacral pedicle screw system1 report
- Xia 3 System - Serrato 482617535Thoracolumbosacral pedicle screw system1 report
- Xia 3 System - Serrato 482617570Thoracolumbosacral pedicle screw system1 report
- Xia 3 System - Serrato 48260245Orthopedic stereotaxic instrument1 report
- Xia 3 System - Serrato 48261330ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Xia 3 System - Serrato 48268012ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent Xia 3 System - Serrato adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE TULIP OF A XIA SERRATO POLYAXIAL SCREW DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 10 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25437546 ↗MalfunctionMar 25, 2026Migration
A HEALTH PROFESSIONAL REPORTED THAT A XIA SERRATO POLYAXIAL SCREW, XIA BLOCKER, AND A XIA ROD MIGRATED APPROXIMATELY ONE MONTH POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED NOR SCHEDULED AT THIS TIME. THIS REPORT CAPTURES THE POLYAXIAL SCREW.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24691079 ↗MalfunctionFeb 26, 2026Device Dislodged or Dislocated
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455764 ↗MalfunctionJan 14, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated
A COMPANY REPRESENTATIVE REPORTED THAT THE TULIP OF A XIA SERRATO POLYAXIAL SCREW DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 5-10 MINUTE SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24076983 ↗InjuryJan 13, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A XIA SERRATO POLYAXIAL SCREW TULIP DISENGAGEMENT, WHICH WAS IDENTIFIED ON POST-OPERATIVE IMAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24064055 ↗InjuryNov 7, 2025Migration; Migration
A CUSTOMER REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY THREE WEEKS POST-OPERATIVELY TO ADDRESS A MIGRATED OIC PEEK SPACER. THE PATIENT REPORTED EXPERIENCING LOW BACK PAIN.
Patient problems: Back pain
MAUDE report 23499000 ↗InjuryOct 3, 2025Fracture; Fracture
InjuryMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
MalfunctionApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A COMPANY REPRESENTATIVE REPORTED THAT THE TULIP OF A XIA SERRATO POLYAXIAL SCREW DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT SCREW WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21877228 ↗MalfunctionNov 27, 2024Inadequacy of Device Shape and/or Size; Use of Device Problem; Inadequacy of Device Shape and/or Size; Use of Device Problem
IT WAS REPORTED THAT THE IDEAL SIZED XIA SERRATO POLYAXIAL SCREW WAS NOT AVAILABLE INTRA-OPERATIVELY, AND THAT SMALLER SIZED XIA SERRATO POLYAXIAL SCREWS WERE IMPLANTED INSTEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO XIA SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20791525 ↗MalfunctionNov 27, 2024Inadequacy of Device Shape and/or Size; Use of Device Problem; Inadequacy of Device Shape and/or Size; Use of Device Problem
IT WAS REPORTED THAT THE IDEAL SIZED XIA SERRATO POLYAXIAL SCREW WAS NOT AVAILABLE INTRA-OPERATIVELY, AND THAT SMALLER SIZED XIA SERRATO POLYAXIAL SCREWS WERE IMPLANTED INSTEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO XIA SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20790009 ↗InjuryNov 14, 2024Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY TWO YEARS POST-OPERATIVELY TO ADDRESS A MIGRATED XIA SERRATO POLYAXIAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20690935 ↗InjuryNov 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A COMPANY REPRESENTATIVE REPORTED THAT THE TULIP OF A XIA SERRATO POLYAXIAL SCREW DISENGAGED FROM THE SCREW SHANK INTRA-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE SCREW WAS REMOVED AND A LONGER SCREW WAS INSERTED INSTEAD. THE PROCEDURE WAS COMPLETED WITH A 10 MINUTE SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20689648 ↗MalfunctionSep 25, 2024Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE SHANK OF A XIA POLYAXIAL SCREW FRACTURED AND COULD NOT BE REMOVED FROM THE PATIENT. NO ADVERSE CONSEQUENCES WERE REPORTED. THE FRACTURED SCREW WAS OBSERVED IN A PLANNED REVISION SURGERY DUE TO ADJACENT INTERVERTEBRAL DISORDERS AND UNRELATED TO ANY ISSUE WITH THE DEVICE. IT IS UNKNOWN IF THE SCREW FRACTURED POST-OPERATIVELY OR INTRA-OPERATIVELY DURING THE REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20304374 ↗MalfunctionMay 20, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
DURING A PLANNED REVISION TO REMOVE THE CONSTRUCT, THE SURGEON NOTED THAT THE TULIP OF A XIA SERRATO POLYAXIAL SCREW HAD FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19356056 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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